Cargando…

Is microdiffusion imaging able to improve the detection of cervical myelopathy? Study protocol of a prospective observational trial (MIDICAM-Trial)

INTRODUCTION: The diagnosis of degenerative cervical myelopathy (DCM) is difficult in numerous patients due to the limited correlation of clinical symptoms, electrophysiology and MRI. This applies especially for early disease stages with mild symptoms or in uncertainty due to comorbidities. Conventi...

Descripción completa

Detalles Bibliográficos
Autores principales: Hohenhaus, Marc, Egger, Karl, Klingler, Jan-Helge, Hubbe, Ulrich, Reisert, Marco, Wolf, Katharina
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6731871/
https://www.ncbi.nlm.nih.gov/pubmed/31481554
http://dx.doi.org/10.1136/bmjopen-2019-029153
_version_ 1783449748243480576
author Hohenhaus, Marc
Egger, Karl
Klingler, Jan-Helge
Hubbe, Ulrich
Reisert, Marco
Wolf, Katharina
author_facet Hohenhaus, Marc
Egger, Karl
Klingler, Jan-Helge
Hubbe, Ulrich
Reisert, Marco
Wolf, Katharina
author_sort Hohenhaus, Marc
collection PubMed
description INTRODUCTION: The diagnosis of degenerative cervical myelopathy (DCM) is difficult in numerous patients due to the limited correlation of clinical symptoms, electrophysiology and MRI. This applies especially for early disease stages with mild symptoms or in uncertainty due to comorbidities. Conventional MRI myelopathy signs show a restricted sensitivity to clinical symptoms of at most 60%. It is desirable to select patients for surgical treatment as early as possible before irreversible neurological damage occurs. To improve treatment, a more reliable imaging is necessary. Microdiffusion imaging (MIDI) is an innovative MRI modality to depict tissue alterations within one voxel based on diffusion-weighted imaging (DWI) postprocessing. By separating the affected area into several mesoscopic compartments, pathological changes might be detected more sensitive through this subtle tissue resolution. We hypothesise, that MIDI shows myelopathic alterations more sensitive than conventional MRI and improves the correlation to functional impairment. METHODS AND ANALYSIS: In this prospective, observational trial, 130 patients with a relevant degenerative cervical spinal stenosis receive MRI including MIDI and a standard clinical and electrophysiological assessment. Special subvoxel diffusion parameters are calculated. Clinical follow-ups are conducted after 3, 6 and with additional MRI and electrophysiology after 12 months. The primary endpoint is the sensitivity of MIDI to detect functional myelopathy defined by clinical and electrophysiological features correlated to conventional MRI myelopathy signs. Twenty healthy subjects will be included as negative control. The results will provide new insights into the development of mesoscopic spinal cord alterations in DCM associated to the clinical course. Aim is to improve the diagnostics of incipient myelopathy through this new modality. ETHICS AND DISSEMINATION: The study protocol is approved by the Ethics Committee of the University of Freiburg (reference 261/17). The results will be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: DRKS00012962.
format Online
Article
Text
id pubmed-6731871
institution National Center for Biotechnology Information
language English
publishDate 2019
publisher BMJ Publishing Group
record_format MEDLINE/PubMed
spelling pubmed-67318712019-09-20 Is microdiffusion imaging able to improve the detection of cervical myelopathy? Study protocol of a prospective observational trial (MIDICAM-Trial) Hohenhaus, Marc Egger, Karl Klingler, Jan-Helge Hubbe, Ulrich Reisert, Marco Wolf, Katharina BMJ Open Radiology and Imaging INTRODUCTION: The diagnosis of degenerative cervical myelopathy (DCM) is difficult in numerous patients due to the limited correlation of clinical symptoms, electrophysiology and MRI. This applies especially for early disease stages with mild symptoms or in uncertainty due to comorbidities. Conventional MRI myelopathy signs show a restricted sensitivity to clinical symptoms of at most 60%. It is desirable to select patients for surgical treatment as early as possible before irreversible neurological damage occurs. To improve treatment, a more reliable imaging is necessary. Microdiffusion imaging (MIDI) is an innovative MRI modality to depict tissue alterations within one voxel based on diffusion-weighted imaging (DWI) postprocessing. By separating the affected area into several mesoscopic compartments, pathological changes might be detected more sensitive through this subtle tissue resolution. We hypothesise, that MIDI shows myelopathic alterations more sensitive than conventional MRI and improves the correlation to functional impairment. METHODS AND ANALYSIS: In this prospective, observational trial, 130 patients with a relevant degenerative cervical spinal stenosis receive MRI including MIDI and a standard clinical and electrophysiological assessment. Special subvoxel diffusion parameters are calculated. Clinical follow-ups are conducted after 3, 6 and with additional MRI and electrophysiology after 12 months. The primary endpoint is the sensitivity of MIDI to detect functional myelopathy defined by clinical and electrophysiological features correlated to conventional MRI myelopathy signs. Twenty healthy subjects will be included as negative control. The results will provide new insights into the development of mesoscopic spinal cord alterations in DCM associated to the clinical course. Aim is to improve the diagnostics of incipient myelopathy through this new modality. ETHICS AND DISSEMINATION: The study protocol is approved by the Ethics Committee of the University of Freiburg (reference 261/17). The results will be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: DRKS00012962. BMJ Publishing Group 2019-09-03 /pmc/articles/PMC6731871/ /pubmed/31481554 http://dx.doi.org/10.1136/bmjopen-2019-029153 Text en © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
spellingShingle Radiology and Imaging
Hohenhaus, Marc
Egger, Karl
Klingler, Jan-Helge
Hubbe, Ulrich
Reisert, Marco
Wolf, Katharina
Is microdiffusion imaging able to improve the detection of cervical myelopathy? Study protocol of a prospective observational trial (MIDICAM-Trial)
title Is microdiffusion imaging able to improve the detection of cervical myelopathy? Study protocol of a prospective observational trial (MIDICAM-Trial)
title_full Is microdiffusion imaging able to improve the detection of cervical myelopathy? Study protocol of a prospective observational trial (MIDICAM-Trial)
title_fullStr Is microdiffusion imaging able to improve the detection of cervical myelopathy? Study protocol of a prospective observational trial (MIDICAM-Trial)
title_full_unstemmed Is microdiffusion imaging able to improve the detection of cervical myelopathy? Study protocol of a prospective observational trial (MIDICAM-Trial)
title_short Is microdiffusion imaging able to improve the detection of cervical myelopathy? Study protocol of a prospective observational trial (MIDICAM-Trial)
title_sort is microdiffusion imaging able to improve the detection of cervical myelopathy? study protocol of a prospective observational trial (midicam-trial)
topic Radiology and Imaging
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6731871/
https://www.ncbi.nlm.nih.gov/pubmed/31481554
http://dx.doi.org/10.1136/bmjopen-2019-029153
work_keys_str_mv AT hohenhausmarc ismicrodiffusionimagingabletoimprovethedetectionofcervicalmyelopathystudyprotocolofaprospectiveobservationaltrialmidicamtrial
AT eggerkarl ismicrodiffusionimagingabletoimprovethedetectionofcervicalmyelopathystudyprotocolofaprospectiveobservationaltrialmidicamtrial
AT klinglerjanhelge ismicrodiffusionimagingabletoimprovethedetectionofcervicalmyelopathystudyprotocolofaprospectiveobservationaltrialmidicamtrial
AT hubbeulrich ismicrodiffusionimagingabletoimprovethedetectionofcervicalmyelopathystudyprotocolofaprospectiveobservationaltrialmidicamtrial
AT reisertmarco ismicrodiffusionimagingabletoimprovethedetectionofcervicalmyelopathystudyprotocolofaprospectiveobservationaltrialmidicamtrial
AT wolfkatharina ismicrodiffusionimagingabletoimprovethedetectionofcervicalmyelopathystudyprotocolofaprospectiveobservationaltrialmidicamtrial